Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

NCT ID: NCT06106282

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-12

Study Completion Date

2025-10-27

Brief Summary

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This study evaluates the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS).

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the effectiveness of a Multidisciplinary Pain Program for AIMSS, specifically determine the impact of the program on level of pain, functional status, and adherence to prescribed medication.

II. To identify predictors of improvement in pain, functional status, and mood following participation in the program.

OUTLINE: This is an observational study.

Patients attend a 2-day treatment program and complete questionnaires on study. Patients also have their medical records reviewed on study.

Conditions

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Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Hormone Receptor-Positive Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Patients attend a 2-day treatment program and complete questionnaires on study. Patients also have their medical records reviewed on study.

Non-Interventional Study

Intervention Type OTHER

Non-Interventional Study

Interventions

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Non-Interventional Study

Non-Interventional Study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients are 18 years old or more.

* A breast cancer survivor ECOG =\< 2, stage 0-III HR+ who is experiencing musculoskeletal symptoms associated with aromatase inhibitors intake
* Patients must be at least 6 months on aromatase inhibitors and for no more than 7 years

Exclusion Criteria

* Breast cancer survivor patients that are not in aromatase inhibitor treatment or have less than 6 months of treatment or more than 7 years of treatment.

* Asymptomatic patients
* Patients less than 18 years old
* Patient that are not being followed as a Mayo Clinic patient

* Patients with stage IV breast carcinoma
* Patients that are HR -
* Patients that are ECOG 3 or more
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara K. Bruce, Ph.D., L.P.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2023-06241

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-003085

Identifier Type: OTHER

Identifier Source: secondary_id

23-003085

Identifier Type: -

Identifier Source: org_study_id

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